BEUDAMED
    FDA Adverse Event Other Summary report: N

    HALO90 ABLATION CATHETER

    MDR report key: 2092929 · Received May 6, 2011

    Report

    Report Number
    3004904811-2011-00011
    Event Type
    Other
    Date Received
    May 6, 2011
    Date of Event
    August 19, 2010
    Report Date
    April 7, 2011
    Manufacturer
    BARRX MEDICAL INC.
    Product Code
    GEI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THIS IS AN ADVERSE EVENT RECORDED ON A CRF AS PART OF THE (B)(6) PT REGISTRY. THE PT IS A MALE WITH 5 CM OF BARRETT'S ESOPHAGUS CONTAINING DYSPLASIA. AFTER A CIRCUMFERENTIAL ABLATION, FOCAL ABLATION WAS SERIALLY PERFORMED FOR RESIDUAL DISEASE. APPROX 1 YR AFTER FOCAL ABLATION, A STRICTURE WAS NOTED. TWO DILATION PROCEDURES HAVE BEEN PERFORMED WITHOUT COMPLICATION. THE PHYSICIAN GRADED THE SEVERITY OF THIS EVENT AS MODERATE, RELATIONSHIP TO THE PROCEDURE AS DEFINITE, AND STATED THERE WAS NO DEVICE MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HALO90 ABLATION CATHETER COAGULATION CATHETER GEI BARRX MEDICAL INC. 90-9100 F1013133

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention